BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA

    MDR report key: 2810031 · Received October 23, 2012

    Report

    Report Number
    3005113652-2012-00103
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON (B)(4) 2012.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED AFTER INJECTION IN THE NASOLABIAL FOLDS OF JUVEDERM ULTRA, THE PATIENT EXPERIENCED "DIFFICULTY TO BREATH" AND WENT TO THE EMERGENCY ROOM. PATIENT WAS TREATED WITH AN TREATMENT NOT PROVIDED IN INITIAL REPORT FOR AN "ALLERGY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention BOTOX